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News

FDA asks Sarepta to stop shipping gene therapy

Digest more
 · 2d · on MSN
Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.

Continue reading

 · 59m · on MSN
Sarepta to pause Elevidys gene therapy shipments in U.S.
MedPage Today · 13h
Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths
Fierce Biotech
14h

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...
19h

Sarepta Stock Continues to Fall After Patient Death Linked to Investigational Gene Therapy

Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...

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